Enoxaparin sodium Ledraxen

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Enoxaparin sodium Ledraxen, 2000 IU (20 mg)/0.2 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium Ledraxen, 4000 IU (40 mg)/0.4 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium Ledraxen, 6000 IU (60 mg)/0.6 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium Ledraxen, 8000 IU (80 mg)/0.8 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium Ledraxen, 10,000 IU (100 mg)/1 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See section 4 for how to report side effects.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Enoxaparin sodium Ledraxen and what is it used for
• 2. Important information before using Enoxaparin sodium Ledraxen
• 3. How to use Enoxaparin sodium Ledraxen
• 4. Possible side effects
• 5. How to store Enoxaparin sodium Ledraxen
• 6. Contents of the pack and other information

1. What is Enoxaparin sodium Ledraxen and what is it used for

Enoxaparin sodium Ledraxen contains the active substance enoxaparin sodium. It belongs to a group of medicines called low molecular weight heparins or LMWHs.
Enoxaparin sodium Ledraxen works in two ways:

• 1) It prevents the growth of existing blood clots. This helps the body to dissolve existing blood clots, so they are no longer harmful.
• 2) It prevents the formation of new blood clots in the patient's blood.

Enoxaparin sodium Ledraxen can be used for:

• Treating blood clots that are already present in the patient's blood.
• Preventing the formation of blood clots in the patient's blood in the following cases: before and after surgery, during a short-term illness when the patient will be unable to move for a period of time

in patients who have developed blood clots in the circulating blood due to cancer, to further prevent the formation of new blood clots

• Preventing the formation of blood clots in unstable angina (when insufficient blood is supplied to the heart muscle) or after a heart attack
• Preventing the formation of blood clots in the tubes of the dialyzer (used in people with severe kidney function disorders).

2. Important information before using Enoxaparin sodium Ledraxen

Do not use Enoxaparin sodium Ledraxen if:

• the patient is allergic to: enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6) heparin or other low molecular weight heparins, such as nadroparin, tinzaparin, or dalteparin. Symptoms of an allergic reaction may include: rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat, or eyes.
• the patient has had a reaction to heparin that caused a significant decrease in the number of blood cells responsible for blood clotting (platelets) in the last 100 days.
• there are antibodies against enoxaparin in the patient's blood.
• the patient has severe bleeding or a medical condition associated with an increased risk of bleeding, such as: stomach ulcers, recent brain or eye surgery, or recent hemorrhagic stroke.
• the patient is taking Enoxaparin sodium Ledraxen to treat blood clots, and a lumbar puncture or surgery under spinal or epidural anesthesia is planned within 24 hours.

Warnings and precautions

Enoxaparin sodium Ledraxen should not be used interchangeably with other low molecular weight heparins.
This is because they are not exactly the same, differ in activity, and have different instructions for use.
Before starting to use Enoxaparin sodium Ledraxen, you should discuss with your doctor or pharmacist if:

• the patient has ever had a reaction to heparin that caused a large decrease in the number of blood cells responsible for blood clotting (platelets)
• the patient has had a heart valve replaced
• the patient has endocarditis (infection of the membrane lining the heart)
• the patient has a history of stomach ulcers
• the patient has recently had a stroke
• the patient has high blood pressure
• the patient has diabetes or has vascular disorders in the eyes caused by diabetes (so-called diabetic retinopathy)
• the patient has recently had eye or brain surgery
• the patient is elderly (over 65 years), especially if they are over 75 years old
• the patient has kidney disease
• the patient has liver disease
• the patient is underweight or overweight
• the patient has an increased level of potassium in the blood (which can be checked with a blood test)
• the patient is currently taking medications that may cause bleeding (see section 2 "Enoxaparin sodium Ledraxen and other medicines").
• the patient has spinal problems or has had spinal surgery.

If any of the above situations apply to the patient or the patient has any doubts, they should discuss this with their doctor or pharmacist before starting to use Enoxaparin sodium Ledraxen.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

Examinations and monitoring

Before starting to use this medicine and periodically during its use, the patient may undergo a blood test to check the number of platelets responsible for blood clotting and the level of potassium in the blood.

Use in children and adolescents

The safety and efficacy of Enoxaparin sodium Ledraxen have not been evaluated in children and adolescents.

Enoxaparin sodium Ledraxen and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.

• warfarin - a medicine used to thin the blood
• aspirin (also known as acetylsalicylic acid or ASA), clopidogrel, or other medicines used to prevent blood clots (see section 3 "Change of anticoagulant medicine")
• dextran injections - used as a blood substitute
• ibuprofen, diclofenac, ketorolac, or other non-steroidal anti-inflammatory medicines used to treat pain and swelling in arthritis and other conditions
• prednisolone, dexamethasone, or other medicines used to treat asthma, rheumatoid arthritis, and other conditions
• medicines that increase the level of potassium in the blood, such as potassium salts, diuretics, or certain heart medicines.

Surgical procedures and anesthetics

If the patient is scheduled for a lumbar puncture or surgery under spinal or epidural anesthesia, they should inform their doctor that they are taking Enoxaparin sodium Ledraxen.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
In pregnant women with a mechanical heart valve, there may be an increased risk of blood clots. The doctor should discuss this with the patient.
Women who are breastfeeding or plan to breastfeed should consult their doctor before starting to use this medicine.

Use in children and adolescents

The safety and efficacy of Enoxaparin sodium Ledraxen have not been evaluated in children and adolescents.

Driving and using machines

Enoxaparin sodium Ledraxen does not affect the ability to drive or use machines.
The doctor should document the trade name and batch number of the medicinal product used.

3. How to use Enoxaparin sodium Ledraxen

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Taking the medicine

• Enoxaparin sodium Ledraxen will usually be given to the patient by a doctor or nurse. This is because it needs to be given by injection.
• Enoxaparin sodium Ledraxen is usually given by subcutaneous injection.
• Enoxaparin sodium Ledraxen may be given by intravenous injection after certain types of heart attack or after surgery.
• Enoxaparin sodium Ledraxen may be introduced into the dialysis tube returning blood to the body (into the so-called arterial line) at the start of the dialysis session.
• Enoxaparin sodium Ledraxen must not be given by intramuscular injection.

Amount of medicine to be given

• The doctor will decide what dose of Enoxaparin sodium Ledraxen the patient should have. This will depend on the reason for using the medicine.
• In patients with kidney disease, the patient may receive a lower dose of Enoxaparin sodium Ledraxen.
• 1) Treatment of blood clots in the patient's blood
• The usual dose is 150 IU (1.5 mg) per kilogram of body weight once a day or 100 IU (1 mg) per kilogram of body weight twice a day.
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen.
• 2) Prevention of blood clots in the patient's blood during surgery or when the patient is unable to move due to illness
• The dose depends on the patient's risk of developing a blood clot. The patient will receive Enoxaparin sodium Ledraxen at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) once a day.
• The first injection is usually given 2 hours or 12 hours before surgery.
• If the patient is unable to move due to illness, they will usually receive Enoxaparin sodium Ledraxen at a dose of 4000 IU (40 mg) once a day.
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen.
• 3) Prevention of blood clots in patients with unstable angina or after a heart attackEnoxaparin sodium Ledraxen can be used in two different types of heart attack. The dose of Enoxaparin sodium Ledraxen will depend on the patient's age and the type of heart attack they have had.

Non-ST-segment elevation myocardial infarction (NSTEMI) (heart attack without ST-segment elevation):

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually also prescribe aspirin (acetylsalicylic acid) for the patient to take.
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen. ST-segment elevation myocardial infarction (STEMI) (heart attack with ST-segment elevation) in patients under 75 years of age:
• The initial dose of Enoxaparin sodium Ledraxen is 3000 IU (30 mg) given intravenously.
• At the same time, Enoxaparin sodium Ledraxen will also be given subcutaneously. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually also prescribe aspirin (acetylsalicylic acid) for the patient to take.
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen. ST-segment elevation myocardial infarction (STEMI) in patients 75 years of age or older:
• The usual dose is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
• The maximum dose of Enoxaparin sodium Ledraxen in the first two doses is 7500 IU (75 mg).
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen.

Patients undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Enoxaparin sodium Ledraxen was given, the doctor may decide to give an additional dose of Enoxaparin sodium Ledraxen before the PCI procedure. The medicine will be given intravenously.

• 4) Prevention of blood clots in the dialyzer tubes
• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Enoxaparin sodium Ledraxen is injected into the tube returning blood to the body (into the so-called arterial line) at the start of the dialysis session. This dose is usually sufficient for a 4-hour dialysis session. However, if necessary, the doctor may give the patient an additional dose of 50 IU to 100 IU (0.5 to 1 mg) per kilogram of body weight. Self-administration of Enoxaparin sodium Ledraxen. If the patient is able to self-administer Enoxaparin sodium Ledraxen, the doctor or nurse will demonstrate how to do it. Do not attempt to self-administer if you have not been trained. If you are unsure, contact your doctor or nurse immediately. Administering the injection properly under the skin (so-called subcutaneous injection) can reduce pain and bruising at the injection site. Before self-administering Enoxaparin sodium Ledraxen
• Prepare all the necessary items: syringe, alcohol swab, soap, and water, and a container for medical waste.
• Check the expiration date on the packaging. Do not use the medicine after the expiration date.
• Check if the syringe is damaged and if the liquid is clear. If not, use another syringe.
• Make sure you know what dose you should inject.
• Examine your abdomen to check if the last injection caused redness, discoloration, swelling, discharge, or if it is still painful. If so, contact your doctor or nurse.

Instructions for syringes without a safety system

• Prepare the injection site: Before injecting, wash your hands and dry them. Use a swab to clean (without rubbing) the chosen injection site. Choose a different area of the abdomen for each injection.
• Remove the protective cap from the needle. It is possible that a drop will form at the tip of the needle. If this happens, remove the drop by tapping the syringe barrel (with the needle facing down).
• Perform the injection: The pre-filled syringe is ready for immediate use. Choose a site on the right or left side of the abdomen. It should be at least 5 cm away from the navel and towards the side. Hold the syringe so that the needle is facing down (at a 90-degree angle), into the thickness of the skin fold created by pinching the skin between the thumb and index finger of the operator. Hold the fold throughout the injection.
• Discard the syringe immediately into a suitable container.

Dispose of any unused medicinal product or waste material in accordance with local regulations.

Instructions for syringes with a safety system

• Prepare the injection site: Before injecting, wash your hands and dry them. Use a swab to clean (without rubbing) the chosen injection site. Choose a different area of the abdomen for each injection.
• First, bend the lock to the side by about 90 degrees. Note: Do not remove the cap before bending the lock.
• Remove the protective cap from the needle. It is possible that a drop will form at the tip of the needle. If this happens, remove the drop by tapping the syringe barrel (with the needle facing down).

• Perform the injection: The pre-filled syringe is ready for immediate use. Choose a site on the right or left side of the abdomen. It should be at least 5 cm away from the navel and towards the side. Hold the syringe so that the needle is facing down (at a 90-degree angle), into the thickness of the skin fold created by pinching the skin between the thumb and index finger of the operator. Hold the fold throughout the injection.

• Secure the needle lock: Using one hand, place the lock on a hard, stable surface. Important: Do not use your finger to secure the needle in the lock. Then press the lock. Bend the lock until the needle clicks into the plastic part.

• Discard the syringe immediately into a suitable container.

After the injection

• 1) To avoid bruising, do not rub the injection site after the injection.
• 2) Dispose of the used syringe into a container for medical waste. Close the container and store it in a place that is out of sight and reach of children. If the container is full, dispose of it in accordance with the doctor's or pharmacist's instructions.

Dispose of any unused medicinal product or waste material in accordance with local regulations.

Change of anticoagulant medicine

• Change from Enoxaparin sodium Ledraxen to medicines that thin the blood, known as vitamin K antagonists (such as warfarin)The doctor will advise the patient to have blood tests to measure the INR and will tell the patient when to stop taking Enoxaparin sodium Ledraxen.
• Change from medicines that thin the blood, known as vitamin K antagonists (such as warfarin), to Enoxaparin sodium LedraxenStop taking the vitamin K antagonist. The doctor will advise the patient to have blood tests to measure the INR and will tell the patient when to start taking Enoxaparin sodium Ledraxen.
• Change from Enoxaparin sodium Ledraxen to direct oral anticoagulantsStop taking Enoxaparin sodium Ledraxen. Then start taking the direct oral anticoagulant 0 to 2 hours before the scheduled time of the next injection; and then continue taking the medicine as usual.
• Change from direct oral anticoagulant to Enoxaparin sodium LedraxenStop taking the direct oral anticoagulant. Treatment with Enoxaparin sodium Ledraxen can start 12 hours after the last dose of the direct oral anticoagulant.

Use of a higher dose of Enoxaparin sodium Ledraxen than recommended

If the patient thinks they have used too much or too little Enoxaparin sodium Ledraxen, they should immediately inform their doctor, pharmacist, or nurse, even if they do not have any symptoms. In case of accidental injection or ingestion of Enoxaparin sodium Ledraxen by a child, immediately go to the hospital emergency department.

Missing a dose of Enoxaparin sodium Ledraxen

If a dose is missed, it should be taken as soon as possible. Do not take a double dose to make up for a missed dose. Keeping a diary helps to ensure that no dose is missed.

Stopping Enoxaparin sodium Ledraxen

It is important to continue injecting Enoxaparin sodium Ledraxen until the doctor tells you to stop. If treatment is stopped, a blood clot may form, which can be very dangerous.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

Stop using Enoxaparin sodium Ledraxen and consult a doctor or nurse immediately if you experience symptoms of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat, or eyes).
If you experience any of the following symptoms, stop using enoxaparin and seek medical attention immediately:

• Red, scaly, widespread rash with thickening of the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Like other similar medicines (used to reduce blood clotting), Enoxaparin sodium Ledraxen may cause bleeding. This can be life-threatening. In some cases, bleeding may not be immediately visible.

You should immediately contact your doctor if:

• the patient experiences any bleeding that does not stop on its own
• the patient has signs of excessive bleeding, such as weakness, fatigue, paleness, dizziness with headaches, or unexplained swelling. The doctor may decide to monitor the patient more closely or change the medicine.

You should immediately contact your doctor:

• if the patient experiences any signs of a blood clot, such as: crampy pain, redness, increased warmth, or swelling in one of the legs - these are symptoms of deep vein thrombosis; shortness of breath, chest pain, fainting, or coughing up blood - these are symptoms of pulmonary embolism.

if the patient experiences painful rash or dark red spots under the skin that do not disappear when pressed. The doctor may order a blood test to check the platelet count.

• if the patient experiences any of the following symptoms, contact a doctor immediately:

Other side effects:

Very common (may affect more than 1 in 10 people):

• bleeding;
• increased liver enzyme activity. Common (may affect up to 1 in 10 people):
• increased tendency to bruise - this may be due to a decrease in the number of platelets in the blood;
• red spots on the skin - these changes are more likely to occur at the injection sites of Enoxaparin sodium Ledraxen;
• skin rash (hives);
• itchy, red skin;
• bruising or pain at the injection site;
• decreased red blood cell count;
• increased platelet count;
• headache. Uncommon (may affect up to 1 in 100 people):
• sudden severe headache - this may be a sign of bleeding in the brain;
• feeling of tenderness and swelling in the stomach - this may be a sign of bleeding in the stomach;
• large, red, irregularly shaped skin changes with blisters or without blisters;
• skin irritation (local irritation);
• the patient may notice yellowing of the skin or eyes and darker urine
• this may indicate liver disease. Rare (may affect up to 1 in 1000 people):
• severe allergic reaction - symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;
• increased level of potassium in the blood - this is more likely to occur in people with kidney disease or diabetes; the doctor may check this with a blood test;
• increased number of eosinophils in the blood - the doctor may check this with a blood test;
• hair loss;
• osteoporosis (a condition in which bones are more prone to fractures) after long-term use of the medicine;
• tingling, numbness, and weakness of the muscles (especially in the lower part of the body) after a lumbar puncture or spinal or epidural anesthesia;
• loss of control over the bladder or bowels (a condition in which the patient is unable to control when they need to go to the toilet);
• hardening or a lump at the injection site.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enoxaparin sodium Ledraxen

Do not store above 25°C.
Do not freeze.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not use this medicine if you notice any changes in the appearance of the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Enoxaparin sodium Ledraxen contains

2000 IU (20 mg)/0.2 mL solution for injection:

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe of 0.2 mL contains 2000 IU of anti-Xa activity (which corresponds to 20 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

4000 IU (40 mg)/0.4 mL solution for injection

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe of 0.4 mL contains 4000 IU of anti-Xa activity (which corresponds to 40 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

6000 IU (60 mg)/0.6 mL solution for injection

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe of 0.6 mL contains 6000 IU of anti-Xa activity (which corresponds to 60 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

8000 IU (80 mg)/0.8 mL solution for injection

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe of 0.8 mL contains 8000 IU of anti-Xa activity (which corresponds to 80 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

10,000 IU (100 mg)/1 mL solution for injection

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe of 1.0 mL contains 10,000 IU of anti-Xa activity (which corresponds to 100 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

What Enoxaparin sodium Ledraxen looks like and contents of the pack

2000 IU (20 mg)/0.2 mL solution for injection:
Colorless or pale yellow, clear liquid
0.2 mL solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging of 1, 2, 6, 10, 20, or 50 pre-filled syringes.
4000 IU (40 mg)/0.4 mL solution for injection:
Colorless or pale yellow, clear liquid
0.4 mL solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging of 1, 2, 6, 10, 20, 30, or 50 pre-filled syringes.
6000 IU (60 mg)/0.6 mL solution for injection:
Colorless or pale yellow, clear liquid
0.6 mL solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging of 1, 2, 6, 10, 12, 20, 24, 30, or 50 pre-filled syringes.
8000 IU (80 mg)/0.8 mL solution for injection:
Colorless or pale yellow, clear liquid
0.8 mL solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging of 1, 2, 6, 10, 12, 20, 24, 30, or 50 pre-filled syringes.
10,000 IU (100 mg)/1 mL solution for injection:
Colorless or pale yellow, clear liquid
1 mL solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging of 1, 2, 6, 10, 12, 20, 24, or 30 pre-filled syringes.
For pre-filled syringes with a capacity of 0.2 mL and 0.4 mL, there is no graduation on the syringe.
For pre-filled syringes with a capacity of 0.6 mL, 0.8 mL, and 1 mL, the syringes are graduated.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Venipharm
4 Bureaux de la Colline
92210 Saint-Cloud
France
+33 1 47 11 0447
venipharm@venipharm.com

Importer

Centre Spécialités Pharmaceutiques
ZAC des Suzots
35 rue de la Chapelle
63450 Saint-Amant Tallende
France

This medicine has been authorized in the EEA member states under the following names:

Austria: Enoxaparin Ledraxen
Cyprus: Ledraxen
Czech Republic: Enoxaparin sodium Ledraxen
Finland: Enoxaparin Ledraxen
Croatia: Enoksaparin natrij Ledraxen
United Kingdom (Northern Ireland): Enoxaparin Ledraxen
Lithuania: Enoxaparin sodium Ledraxen
Latvia: Enoxaparin sodium Ledraxen
Norway: Enoxaparin Ledraxen
Poland: Enoxaparin sodium Ledraxen
Portugal: Enoxaparina sódica Ledraxen
Slovakia: Ledraxen
Slovenia: Enoksaparin Ledraxen
Germany: Enoxaparin Ledraxen
France: Enoxaparine Arrow
Sweden: Enoxaparin Ledraxen
Spain: Enoxaparina Ledraxen

Date of last revision of the leaflet: 06/2023

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Website: https://smz.ezdrowie.gov.pl